The recent decision by the South African Department of Health to
withdraw the provision of free replacement (formula) feeds to
HIV-exposed infants has hardly evoked any response from clinicians,
health professionals or civil society groups. This paper argues that the
decision is short-sighted, lacks an adequate evidence base, and is
retrogressive and unconstitutional. Nine supporting arguments are
presented and an alternative policy proposed.

The recent 'Tshwane Declaration of Support for Breastfeeding
in South Africa' championed by the national Department of Health
seeks to promote breastfeeding and halt practices deterring optimal
breastfeeding in South Africa (SA). (1) The Declaration's
intentions are most welcome, including greater support for the Baby
Friendly Hospital Initiative which facilitates breastfeeding soon after
birth, increasing numbers of community health promoters who will visit
homes and support mothers with breastfeeding, workplace support for
breastfeeding mothers, and stricter monitoring of the milk
industry's compliance with the code of marketing of breastmilk
substitutes.

However, one decision stands out as short-sighted, poorly evidenced
and retrogressive. The plan to remove the provision of free replacement
(formula) feeding to infants of HIV-positive women is frankly
bewildering. HIV accounts for over 50% of child mortality in SA, (2) and
is primarily responsible for the loss of hard-earned gains in child
health in South Africa over the past two decades. Postnatal transmission
of HIV through breastfeeding is now the commonest form of
mother-to-child transmission (MTCT), and its contribution is increasing
as programmes introduce more effective antenatal and perinatal ARV
regimens. Annually, more than half a million infants globally acquire
HIV through breastfeeding, highlighting the failure of previous
strategies, including those promoting exclusive breastfeeding.

There are currently only two recognised postnatal preventive
strategies--antiretroviral prophylaxis provided to mother or infant, and
avoiding HIV exposure through replacement feeding. To deliberately
discard one of these two strategies is a luxury that the country can ill
afford and requires substantial evidence that the strategy is either
ineffective or results in major harm. Evidence to support either of
these contentions in the South African setting is simply lacking.

Multiple strategies are currently available to prevent HIV
transmission in adults. Despite good evidence about the benefit of
condoms, microbicides, circumcision and pre- and post-exposure
prophylaxis, among others, the search continues for different and more
effective prevention options such as an HIV vaccine. Clearly, a single
strategy could never meet the needs of all. If the Department of Health
were to summarily withdraw the provision of any one of the established
HIV prevention strategies, the HIV community would be toyi-toying in the
streets.

Yet the government's decision to remove a well-evidenced child
HIV prevention strategy--replacement feeding--has hardly elicited a
whisper from HIV activists, clinicians or civil society. Is it that they
have been cowed into inaction because supporting replacement feeding is
somehow automatically viewed as being anti-breast? Certainly, this was
the fate of the authors of this piece when we recently wrote an opinion
piece in the Mail & Guardian questioning the validity of the
Department's decision. (3) Supporters of the Department's
proposal lambasted the newspaper's irresponsible behaviour in
publishing the piece. They went on to describe us as ill-informed and
'dissidents'. (4) Such malicious name-calling demonstrates a
degree of intolerance unbecoming of fellow scientists on a decision that
has great scientific and public health importance and deserves rigorous
debate.

Indeed, at an open public debate hosted by the SA HIV Clinicians
Society in Johannesburg in October 2011, over 70% of the more than 120
attendees (who included doctors, nurses, policy makers and
nutritionists) voted against the Department's proposed change. A
similar percentage of attendees agreed that provinces should be free to
determine their own policy rather than being forced to offer a single
option. Clearly the views of many important stakeholders have not been
considered in the Department's decision, and there appear to be
many dissidents lurking out there. The most silent voice has been that
of HIV-positive women.

NO EVIDENCE THAT THE NEW PROPOSAL WILL MAXIMISE HIV-FREE CHILD
SURVIVAL IN SA

Supporters of the withdrawal of replacement feeding will quickly
point out that it is not just the acquisition of HIV infection but
overall child survival (HIV-exposed children staying alive) that
matters. That is correct. The pertinent question then is whether
replacement feeding inevitably results in increased child mortality in
SA. The primary author of the Mail & Guardian piece attacking our
stance readily acknowledged in a paper published in the Bulletin of the
World Health Organization in 2011 that "... no determination has
been made about which feeding practice will maximize HIV-free survival
nationally'. (5)

Much of the evidence arguing that HIV-free survival (being alive
and HIV uninfected) is similar for formula-fed and exclusively breastfed
infants originates from countries such as Zambia, Malawi and rural
Botswana. However, the extremely high background mortality in the study
children (e.g. 21% in Zambia) (6) because of the high burden of
infectious disease, poor hygiene and sanitation, and limited access to
quality health care, easily masks any possible benefits of replacement
feeding (since so many children die). These dismal conditions are much
less likely in South African settings. In rural KwaZulu-Natal, for
instance, the probability of HIV-free survival at 18 months was
marginally higher in HIV-exposed infants who had never been breastfed
compared with infants who had ever been exclusively breastfed (80% v.
75%, p=0.05), the difference being mostly attributed to acquisition of
infection through breastfeeding. (7) A second confounder present in most
studies is that since few trials randomised feeding choice, higher-risk
women (with lower CD4 counts) were directed to, or selected, replacement
feeding. This obviously attenuates possible benefits of replacement
feeding.

Evidence from diverse African cities such as Nairobi (8) and
Abidjan (9) convincingly indicates that replacement feeding can be
safely supported in these settings and can reduce HIV infection rates,
without jeopardising child survival. With safe replacement feeding, the
vertical HIV transmission rate can be reduced to less than 2%, even in a
resource-limited setting such as rural Rwanda. (10) The high HIV-free
survival rate reported in the Rwandan cohort of infants whose caregivers
were supported with exclusive replacement feeding is remarkable and
among the highest reported for a cohort of HIV-exposed infants. (10)

SOUTH AFRICA IS NOT A SINGLE HOMOGENEOUS COUNTRY

Using data from poorer southern African countries to argue that
replacement (formula) feeding cannot be undertaken safely in SA is
inappropriate. Over half of South African children are urbanised. (11)
Many have good access to safe water (62%), sanitation (63%) and
electricity, and these statistics exceed 87% in Gauteng and the Western
Cape, including their townships and informal settlements. (12) Under-5
mortality rates (U5MR) vary substantially among provinces and districts;
for example, in 2008 the U5MR in Western Cape was 31/1 000 live births,
while it was almost fourfold higher in the Free State (117/1 000). (13)
District-level data are unavailable.

At least a third to one-half of SA caregivers should therefore be
able to safely replacement feed their children. SA data from peri-urban
and rural settings such as Paarl, Umlazi and Rietvlei confirm that
formula feeding halved HIV transmission or death among children living
in households with piped water. Among those who had piped water and fuel
and who disclosed their HIV status, the protective effect of formula was
greater (68% reduction). (14) Furthermore, the increasing availability
of rotavirus and pneumococcal vaccine in SA is rapidly reducing the
incidence and severity of diarrhoea and pneumonia, two major morbidities
associated with replacement feeding.

This does not mean that that choosing to formula feed an infant in
some rural parts of the country, or in an under-serviced informal
settlement, could ever be considered an appropriate choice. However,
denying individual choice and failing to support a legitimate HIV
prevention strategy in circumstances where this can be safely done
violates caregivers' and infants' rights to basic health care
and may be unconstitutional.

A SINGLE INFANT FEEDING OPTION IS INAPPROPRIATE FOR ALL
HIV-POSITIVE WOMEN IN SA

A 'one-size-fits-all policy' is certainly simpler to
promote, and the notion that 'mixed messages lead to mixed
feeding' makes sense. However, the simplest policy is not
necessarily the best. Until recently infant feeding policy in SA was
made at the provincial level. This makes sense because SA is
heterogeneous in so many respects--the rural-urban mix, the availability
of water and sanitation, the background infant mortality and the
provincial variation in the percentage of mothers with HIV. The newly
proposed policy demands that the whole country assume the same
position--no free formula provision. This position is contrary even to
the 2010 WHO HIV and infant feeding policy, on which the South African
policy is based, which recommended that decisions be made by
'national or sub-national health authorities' in recognition
of in-country variances. (15)

THE NEW PROPOSAL IS RETROGRESSIVE IN TERMS OF SUPPORTING
WOMEN'S CHOICE AND ANTI-POOR

Arguing that parents can pay for formula from their own pockets if
they choose this option may seem reasonable, but this denies access to
an estimated 25 000 infants in whom formula feeding may be safely
undertaken, but is unaffordable. Data from Rietvlei, Paarl and Umlazi
confirmed that as many as a third of women living in these peri-urban
and rural settings met the adequacy for replacement feeding criteria,
dubbed AFASS (affordable, feasible, acceptable, sustainable, safe),
despite being poor. (14) Disallowing middle- and upper-class women
access to free state-sponsored formula may be justifiable, since access
to many health services for this class of citizens require them to bear
the costs themselves. However, insisting that a poor woman (who
qualifies for a child support grant, for instance) who meets the AFASS
criteria be denied the opportunity to have an HIV-uninfected child,
simply because she is poor, is discriminatory.

THE NEW PROPOSAL IS BASED ON EXTRAPOLATION RATHER THAN FIRM
EVIDENCE

Much of the enthusiasm for the proposal to withdraw support for
replacement feeding stems from research suggesting that extended
nevirapine provision to infants for 6 months, or triple antiretroviral
therapy provision to their mothers, can reduce HIV transmission rates to
less than 2% at 6 months in exclusively breastfed populations. Whether
the benefits of antiretroviral prophylaxis continue to 12 months (the
suggested duration in SA), and whether the intervention is equally
beneficial in mixed-fed infants (the likely situation in SA), is
unknown. Similarly, the consequences of antiretroviral interruption
while breastfeeding are unclear. There are further unanswered questions.
How serious are the long-term effects of exposure to multiple
antiretroviral drugs in utero and during breastfeeding? Can adequate
adherence be achieved to avoid emergence of drug resistance? Will there
be negative effects on discontinuation of antiretroviral therapy (ART)
after stopping breastfeeding in women who do not require it for their
own health?

THE ABILITY OF THE HEALTH SYSTEM TO SUPPORT THE NEW PROPOSAL IS NOT
GUARANTEED--FAILURE TO DELIVER WILL HAVE DRASTIC CONSEQUENCES

The new proposal is a huge public health experiment and could even
be considered a high-stake gamble. While nevirapine toxicity does not
seem cumulative, the adherence and programmatic challenges of long-term
prophylaxis are untested. Extrapolating data from highly controlled
experimental settings to real-world situations is risky, particularly in
the absence of a single local pilot project demonstrating successful
implementation. At present, not one province has any monitoring or
evaluation plan to establish effectiveness.

Perhaps the most pertinent question is whether many South African
settings that are still battling to provide single-dose nevirapine or
dual therapy are capable of offering this new standard of care. What
should not be under-estimated are the demands on the health system of
the new proposal. It is anticipated that of the approximately 300 000
HIV-positive pregnant women each year, about half will qualify for ART
(for life) for their own health. For these mothers ensuring adherence is
the major issue, since their infants will not be receiving nevirapine,
and if the mother stops taking ART her infant will be left with no
prophylaxis. Mothers not qualifying for ART need to be convinced to
exclusively breastfeed for 6 months, and to provide their healthy
uninfected infants with a daily dose of a drug (nevirapine) for up to
one year. The health service will need to monitor these children at
least monthly and ensure that drug supplies do not falter. The benefit
of extended nevirapine if a mother starts mixed feeding or forgets to
provide the drug for any period is unknown.

A failure to meet any of these requirements will mean that
transmission rates of infant HIV could start escalating again. All the
problems of ensuring an adequate formula supply that have plagued the
PMTCT programme will be replicated with extended nevirapine or ART
provision, except that the consequences of a failed supply line will be
far worse; while mothers still had to feed their infants and make
alternative plans when formula was scarce, it is less likely that they
will do so when nevirapine or ARTs runs out at a clinic.

Little consideration seems to have been taken in the new proposal
of the myriad of situations where initiation or continuation of
breastfeeding of HIV-exposed infants will not be possible, such as
mothers returning to work or school, grannies caring for grandchildren,
and abandoned or orphaned children.

During this time of fiscal restraint where healthcare resources are
finite, information about both effectiveness and costs is important for
policy makers as evidence-based decisions are made. When the issue of
costs was raised during the recent breastfeeding consultation, the
comment that 'a back of the envelope calculation shows that
breastfeeding is much cheaper and more cost-effective than formula and
could save R200 million a year' was met with wild applause. This
type of feeble evidence to support a major policy shift is unfortunate.
Cost, logistics and cultural preferences should be considered in policy
decisions.

A new, unpublished modelling exercise using SA data indicates that
extended nevirapine is a cost-saving intervention in both typical urban
and rural settings and results in improved HIV-free survival. Changing
feeding practices to promote breastfeeding is cost-saving in typical
rural settings, while promoting replacement feeding in typical urban
settings is the most cost-effective feeding option (personal
communication, Mandy Maredza, 1 November 2011).

AN HIV-FREE GENERATION CAN NEVER BE ACHIEVED WHILE BREASTFEEDING
CONTINUES

The current call and challenge posed by the UNAIDS, and taken up in
SA national policy, to eliminate MTCT by 2015 (i.e. zero new HIV
infections) is unlikely to be achieved with a single strategy for infant
feeding in SA, since at least 6 000 new infections annually can be
expected in breastfeeding infants provided extended nevirapine. In
reality there will be many more infected children, since implementation
will hardly be perfect because of imperfect behavioural compliance. In
the rush to ensure that SA is on a path to decreasing child mortality
from all causes it is critical to ensure that recent gains in the number
of HIV-exposed children's lives saved through existing
interventions, including replacement feeding, are not erased.

WHAT A NEW POLICY SHOULD SAY

A more appropriate infant feeding policy for the country would
offer antiretroviral prophylaxis and breastfeeding as the national
default option. However, provinces, and perhaps even districts, should
be allowed the freedom to decide whether they wish to continue to
support the provision of replacement feeding for poor women who meet the
AFASS criteria, based on their own circumstances. Whatever choice women
ultimately make, much more emphasis needs to be placed on a more
supportive environment including adequate counselling, education and
support through community health workers.

The availability of antiretroviral prophylaxis is a big step
forward for HIV-positive women choosing to breastfeed their infants.
It's a crying shame that in introducing this promising
intervention, the Department of Health has chosen to take the low road
(by insisting on a single option) rather than following the high one
where the provision of safe water, sanitation and other resources, and
employment would also have been prioritised for all citizens, so that
any parents wanting to guarantee a HIV-free future for their child could
do so knowing that the choice of replacement feeding could be safely
supported too.

REFERENCES

(1.) The Tshwane Declaration of breastfeeding in South Africa.
http://www.confcall.co.za/ presentation Downloads.php?recordId=8
(accessed 13 November 2011).